Diagnostic trials
Test the best way to detect disease or changes within the body

Natural History trials
Study the natural course of disease in the human body

Quality of Life trials
Study ways to improve aspects of life for people living with illnesses

The Basic Components of Clinical Trials

The scientists and health care providers who manage clinical trials are usually called investigators. The people who join clinical trials are usually called participants, but may be referred to as volunteers or study subjects. ALL clinical trials are voluntary – you never have to participate in a clinical trial unless you want to; this is a human right protected by international laws.

In 2002, the World Health Organization (WHO) released a Handbook for Good Clinical Research Practice, which was intended as a guide for each country to develop its own laws governing clinical trials. The WHO's handbook is based in part on the recommendations for good clinical practice set forth by the International Conference on Harmonisation (ICH) in 1996. In the US, for example, the Food and Drug Administration (FDA), which approves drugs for public use, has adopted the ICH's guidance on good clinical practice for clinical trials.

Each clinical trial has a written plan, or study protocol, that describes the goals of the study, how long the study will last, who is eligible to participate (also called inclusion and exclusion criteria), and what tests and procedures are required of each participant.

Inclusion and exclusion criteria are the guidelines used to determine who can and cannot participate in a specific clinical trial. Inclusion criteria are requirements that a person must meet to participate (such as HIV drug-naïve, or never having taken HIV drugs, CD4 cell count, viral load, age, or many others). Exclusion criteria are factors that prevent a person from participating either for his or her safety or to make it easier to understand the study results. For example, people might be excluded for having liver problems, or if they have already taken a drug that is being studied.

Each participant in a clinical trial must sign an informed consent. When you sign this document it means that you understand the details of the study and you agree to participate. You may want to take the document with you and talk about the study with your health care provider, family, or friends before you decide to participate. If your native language is not the language spoken by the people describing the study, you should ask if translation is available. It is important that you truly understand the study and what you will be asked to do. If you have any questions, be sure to ask the study staff. It is their job to make sure that, when you sign, you are making an informed choice and understand what you are agreeing to do in signing the document.

You may be paid for travel expenses to and from the study site and for your time; this payment is sometimes called compensation. Childcare may also be provided. You can choose to drop out of a study at any time and for any reason.

The Stages of Treatment Trials

The most common type of clinical trial in HIV is a treatment or drug study. There are four stages, or phases, of clinical trials for new treatments. With each phase, a little more is known about the treatment being studied. Each phase has a different purpose and helps researchers answer specific questions about the drug in trial.

Phase I: Is the drug safe?
A Phase I trial tests a drug in a small number of participants (usually fewer than 100) to find a safe dose and to document the side effects of the drug. Phase I trials are usually short, lasting a few days to a few weeks.

Phase II: Is the drug effective?
A Phase II trial tests a drug in a larger number of participants (on average 100 to 300) to see if the drug works. Phase II trials may also test different doses of the drug to find which dose works best. The safety of the drug also continues to be evaluated. A Phase II trial usually lasts six months to one year.

Phase III: Is the drug safe and effective in larger groups of people for longer periods of time?
A Phase III trial tests a drug in a very large group of participants (typically 1,000 to 3,000). Phase III trials gather more information about the safety and effectiveness of the drug by comparing it to an existing medication or treatment. Phase III trials generally last two to three years.

Phase IV or Post-Marketing studies:
What are the long-term results of using the drug? These trials are done after US Food and Drug Administration (FDA) approval to get more information about the drug's best use and to further examine long-term side effects.

Once a drug trial has completed the first three phases of research, the company that makes the drug submits the study data to the FDA for approval. Because the need for treatments for HIV is so great, a drug company can apply for something called accelerated, or quicker, approval if its drug offers something new or meets a need for people living with HIV (HIV+).

Accelerated approval may put special restrictions on how the drug can be used. However, even if a drug gets accelerated approval, the drug company must continue doing long-term research on the drug for it to get full approval.

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